InRoad® Dental Synthetic Bone Graft HA90D05L

GUDID 10810051880011

InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic for bone regeneration. It is comprised of 90% ± 5% hydroxyapatite (HA) and 10% ± 5% Beta-Tricalcium Phosphate. The granules are provided sterile (gamma irradiated) in a capped vial packaged in a lid sealed tray. InRoad® Dental SBG granules are designed to resemble trabecular bone structure. The granule structure consists of interconnected primary open pores, secondary channel-like structure, and tertiary small holes on the surface in a biocompatible and osteoconductive biomaterial. The multi-porous structure of InRoad® Dental SBG makes it possible for the bone cells to migrate into the matrices and for new bone to grow. InRoad® Dental SBG is available in granule form in sizes of 0.3 – 1.0 mm (Small) and 0.8 – 1.8 mm (Large).

Osteogene Tech Corp

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 10810051880011
• NIH Device Record Key: 1cebc764-29e9-4c9c-9ca6-3bbbf9411494
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InRoad® Dental Synthetic Bone Graft
• Version Model Number: HA90D Large (0.8 – 1.8 mm) 0.5 cc
• Catalog Number: HA90D05L
• Company DUNS: 044161695
• Company Name: Osteogene Tech Corp
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-367-9321
• Email: info@osteogene.com
• Phone: 201-367-9321
• Email: info@osteogene.com
• Phone: 201-367-9321
• Email: info@osteogene.com
• Phone: 201-367-9321
• Email: info@osteogene.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810051880011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202675

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-02
• Device Publish Date: 2022-05-25

On-Brand Devices [InRoad® Dental Synthetic Bone Graft]

• 10810051880066: InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic fo
• 10810051880059: InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic fo
• 10810051880042: InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic fo
• 10810051880035: InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic fo
• 10810051880028: InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic fo
• 10810051880011: InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic fo
• 10810051880080: InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic fo
• 10810051880073: InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense multi-porous bioceramic fo